Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781358
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Number Unique Device Identifier (UDI#) Model: 781358 45153 (01)00884838088115(21)45153 45062 (01)00884838088115(21)45062 45107 (01)00884838088115(21)45107 45144 (01)00884838088115(21)45144 45145 (01)00884838088115(21)45145 45142 (01)00884838088115(21)45142 45215 (01)00884838088115(21)45215 45216 (01)00884838088115(21)45216 45284 (01)00884838088115(21)45284 45079 (01)00884838088115(21)45079 45121 (01)00884838088115(21)45121 45007 (01)00884838088115(21)45007 45154 (01)00884838088115(21)45154 45127 (01)00884838088115(21)45127 45052 (01)00884838088115(21)45052 45193 (01)00884838088115(21)45193 45253 (01)00884838088115(21)45253 45042 (01)00884838088115(21)45042 45045 (01)00884838088115(21)45045 45136 (01)00884838088115(21)45136 45119 (01)00884838088115(21)45119 45197 (01)00884838088115(21)45197 45195 (01)00884838088115(21)45195 45097 (01)00884838088115(21)45097 45106 N/A 45131 N/A 45259 (01)00884838088115(21)45259 45300 (01)00884838088115(21)45300 45313 (01)00884838088115(21)45313 45298 (01)00884838088115(21)45298 45265 (01)00884838088115(21)45265 45000 (01)00884838088115 45039 (01)00884838088115(21)45039 45047 (01)00884838088115(21)45047 45080 (01)00884838088115(21)45080 45056 (01)00884838088115(21)45056 45137 (01)00884838088115(21)45137 45129 (01)00884838088115(21)45129 45109 (01)00884838088115(21)45109 45171 (01)00884838088115(21)45171 45205 (01)00884838088115(21)45205 45210 (01)00884838088115(21)45210 45188 (01)00884838088115(21)45188 45297 (01)00884838088115(21)45297 45071 (01)00884838088115(21)45071 45098 (01)00884838088115(21)45098 45140 (01)00884838088115(21)45140 45246 (01)00884838088115(21)45246 45159 (01)00884838088115(21)45159 45031 (01)00884838088115(21)45031 45044 (01)00884838088115(21)45044 45043 (01)00884838088115(21)45043 45040 (01)00884838088115(21)45040 45065 (01)00884838088115(21)45065 45070 (01)00884838088115(21)45070 45260 (01)00884838088115(21)45260 45088 (01)00884838088115(21)45088 45096 (01)00884838088115(21)45096 45128 (01)00884838088115(21)45128 45134 (01)00884838088115(21)45134 45111 (01)00884838088115(21)45111 45190 (01)00884838088115(21)45190 45218 (01)00884838088115(21)45218 45139 (01)00884838088115(21)45139 45241 (01)00884838088115(21)45241 45025 (01)00884838088115(21)45025 45114 (01)00884838088115(21)45114 45151 (01)00884838088115(21)45151 45148 (01)00884838088115(21)45148 45160 (01)00884838088115(21)45160 45176 (01)00884838088115(21)45176 45274 (01)00884838088115(21)45274 45276 (01)00884838088115(21)45276 45282 (01)00884838088115(21)45282 45248 (01)00884838088115(21)45248 45138 (01)00884838088115(21)45138 45295 (01)00884838088115(21)45295 45033 (01)00884838088115(21)45033 45048 (01)00884838088115(21)45048 45037 (01)00884838088115(21)45037 45050 (01)00884838088115(21)45050 45049 (01)00884838088115(21)45049 45046 (01)00884838088115(21)45046 45034 (01)00884838088115(21)45034 45066 (01)00884838088115(21)45066 45061 (01)00884838088115(21)45061 45076 (01)00884838088115(21)45076 45072 (01)00884838088115(21)45072 45077 (01)00884838088115(21)45077 45090 (01)00884838088115(21)45090 45041 (01)00884838088115(21)45041 45091 (01)00884838088115(21)45091 45093 (01)00884838088115(21)45093 45102 (01)00884838088115(21)45102 45105 (01)00884838088115(21)45105 45120 (01)00884838088115(21)45120 45064 (01)00884838088115(21)45064 45084 (01)00884838088115(21)45084 45170 (01)00884838088115(21)45170 45118 (01)00884838088115(21)45118 45163 (01)00884838088115(21)45163 45116 (01)00884838088115(21)45116 45149 (01)00884838088115(21)45149 45141 (01)00884838088115(21)45141 45162 (01)00884838088115(21)45162 45185 (01)00884838088115(21)45185 45115 (01)00884838088115(21)45115 45186 (01)00884838088115(21)45186 45189 (01)00884838088115(21)45189 45211 (01)00884838088115(21)45211 45250 (01)00884838088115(21)45250 45224 (01)00884838088115(21)45224 45272 (01)00884838088115(21)45272 45281 (01)00884838088115(21)45281 45212 (01)00884838088115(21)45212 45231 (01)00884838088115(21)45231 45290 (01)00884838088115(21)45290 45314 (01)00884838088115(21)45314 45323 (01)00884838088115(21)45323 45268 (01)00884838088115(21)45268 45123 (01)00884838088115(21)45123 45122 (01)00884838088115(21)45122 45169 N/A 45168 (01)00884838088115(21)45168 45191 (01)00884838088115(21)45191 45220 (01)00884838088115(21)45220 45204 (01)00884838088115(21)45204 45192 N/A 45229 (01)00884838088115(21)45229 45203 (01)00884838088115(21)45203 45222 (01)00884838088115(21)45222 45228 (01)00884838088115(21)45228 45207 (01)00884838088115(21)45207 45249 (01)00884838088115(21)45249 45279 (01)00884838088115(21)45279 45278 (01)00884838088115(21)45278 45320 (01)00884838088115(21)45320 45156 (01)00884838088115(21)45156 45157 (01)00884838088115(21)45157 45085 (01)00884838088115(21)45085 45303 (01)00884838088115(21)45303 45304 (01)00884838088115(21)45304 45307 (01)00884838088115(21)45307 45305 (01)00884838088115(21)45305 45306 (01)00884838088115(21)45306 45308 (01)00884838088115(21)45308 45309 (01)00884838088115(21)45309 45311 (01)00884838088115(21)45311 45310 (01)00884838088115(21)45310 45312 (01)00884838088115(21)45312 45267 (01)00884838088115(21)45267 45001 (01)00884838088115 45008 (01)00884838088115(21)45008 45009 N/A 45036 (01)00884838088115(21)45036 45181 (01)00884838088115(21)45181 45184 (01)00884838088115(21)45184 45227 (01)00884838088115(21)45227 45217 (01)00884838088115(21)45217 45187 N/A 45292 (01)00884838088115(21)45292 45219 (01)00884838088115(21)45219 45180 (01)00884838088115(21)45180 45067 (01)00884838088115(21)45067 45094 (01)00884838088115(21)45094 45183 (01)00884838088115(21)45183 45081 (01)00884838088115(21)45081 45095 (01)00884838088115(21)45095 45028 (01)00884838088115(21)45028 45029 N/A 45030 (01)00884838088115(21)45030 45165 (01)00884838088115(21)45165 45158 (01)00884838088115(21)45158 45177 (01)00884838088115(21)45177 45174 (01)00884838088115(21)45174 45002 (01)00884838088115 45010 (01)00884838088115(21)45010 45011 (01)00884838088115(21)45011 45026 (01)00884838088115(21)45026 45027 (01)00884838088115(21)45027 45024 (01)00884838088115(21)45024 45035 (01)00884838088115(21)45035 45032 (01)00884838088115(21)45032 45051 (01)00884838088115(21)45051 45054 (01)00884838088115(21)45054 45053 (01)00884838088115(21)45053 45078 (01)00884838088115(21)45078 45068 (01)00884838088115(21)45068 45089 (01)00884838088115(21)45089 45082 (01)00884838088115(21)45082 45055 (01)00884838088115(21)45055 45086 (01)00884838088115(21)45086 45060 (01)00884838088115(21)45060 45100 (01)00884838088115(21)45100 45112 (01)00884838088115(21)45112 45099 (01)00884838088115(21)45099 45075 (01)00884838088115(21)45075 45087 (01)00884838088115(21)45087 45108 (01)00884838088115(21)45108 45113 (01)00884838088115(21)45113 45146 (01)00884838088115(21)45146 45124 (01)00884838088115(21)45124 45147 (01)00884838088115(21)45147 45164 (01)00884838088115(21)45164 45150 (01)00884838088115(21)45150 45133 (01)00884838088115(21)45133 45152 (01)00884838088115(21)45152 45161 (01)00884838088115(21)45161 45178 (01)00884838088115(21)45178 45132 (01)00884838088115(21)45132 45179 (01)00884838088115(21)45179 45194 (01)00884838088115(21)45194 45237 (01)00884838088115(21)45237 45236 (01)00884838088115(21)45236 45238 (01)00884838088115(21)45238 45243 (01)00884838088115(21)45243 45252 (01)00884838088115(21)45252 45245 (01)00884838088115(21)45245 45263 (01)00884838088115(21)45263 45261 (01)00884838088115(21)45261 45269 (01)00884838088115(21)45269 45264 (01)00884838088115(21)45264 45247 (01)00884838088115(21)45247 45296 (01)00884838088115(21)45296 45321 (01)00884838088115(21)45321 45092 (01)00884838088115(21)45092 45155 (01)00884838088115(21)45155 45058 N/A
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Philips North America Llc
- Reason for Recall:
- When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- completed
Product Information
Full Description:
Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781358
Product Codes/Lot Numbers:
Serial Number Unique Device Identifier (UDI#) Model: 781358 45153 (01)00884838088115(21)45153 45062 (01)00884838088115(21)45062 45107 (01)00884838088115(21)45107 45144 (01)00884838088115(21)45144 45145 (01)00884838088115(21)45145 45142 (01)00884838088115(21)45142 45215 (01)00884838088115(21)45215 45216 (01)00884838088115(21)45216 45284 (01)00884838088115(21)45284 45079 (01)00884838088115(21)45079 45121 (01)00884838088115(21)45121 45007 (01)00884838088115(21)45007 45154 (01)00884838088115(21)45154 45127 (01)00884838088115(21)45127 45052 (01)00884838088115(21)45052 45193 (01)00884838088115(21)45193 45253 (01)00884838088115(21)45253 45042 (01)00884838088115(21)45042 45045 (01)00884838088115(21)45045 45136 (01)00884838088115(21)45136 45119 (01)00884838088115(21)45119 45197 (01)00884838088115(21)45197 45195 (01)00884838088115(21)45195 45097 (01)00884838088115(21)45097 45106 N/A 45131 N/A 45259 (01)00884838088115(21)45259 45300 (01)00884838088115(21)45300 45313 (01)00884838088115(21)45313 45298 (01)00884838088115(21)45298 45265 (01)00884838088115(21)45265 45000 (01)00884838088115 45039 (01)00884838088115(21)45039 45047 (01)00884838088115(21)45047 45080 (01)00884838088115(21)45080 45056 (01)00884838088115(21)45056 45137 (01)00884838088115(21)45137 45129 (01)00884838088115(21)45129 45109 (01)00884838088115(21)45109 45171 (01)00884838088115(21)45171 45205 (01)00884838088115(21)45205 45210 (01)00884838088115(21)45210 45188 (01)00884838088115(21)45188 45297 (01)00884838088115(21)45297 45071 (01)00884838088115(21)45071 45098 (01)00884838088115(21)45098 45140 (01)00884838088115(21)45140 45246 (01)00884838088115(21)45246 45159 (01)00884838088115(21)45159 45031 (01)00884838088115(21)45031 45044 (01)00884838088115(21)45044 45043 (01)00884838088115(21)45043 45040 (01)00884838088115(21)45040 45065 (01)00884838088115(21)45065 45070 (01)00884838088115(21)45070 45260 (01)00884838088115(21)45260 45088 (01)00884838088115(21)45088 45096 (01)00884838088115(21)45096 45128 (01)00884838088115(21)45128 45134 (01)00884838088115(21)45134 45111 (01)00884838088115(21)45111 45190 (01)00884838088115(21)45190 45218 (01)00884838088115(21)45218 45139 (01)00884838088115(21)45139 45241 (01)00884838088115(21)45241 45025 (01)00884838088115(21)45025 45114 (01)00884838088115(21)45114 45151 (01)00884838088115(21)45151 45148 (01)00884838088115(21)45148 45160 (01)00884838088115(21)45160 45176 (01)00884838088115(21)45176 45274 (01)00884838088115(21)45274 45276 (01)00884838088115(21)45276 45282 (01)00884838088115(21)45282 45248 (01)00884838088115(21)45248 45138 (01)00884838088115(21)45138 45295 (01)00884838088115(21)45295 45033 (01)00884838088115(21)45033 45048 (01)00884838088115(21)45048 45037 (01)00884838088115(21)45037 45050 (01)00884838088115(21)45050 45049 (01)00884838088115(21)45049 45046 (01)00884838088115(21)45046 45034 (01)00884838088115(21)45034 45066 (01)00884838088115(21)45066 45061 (01)00884838088115(21)45061 45076 (01)00884838088115(21)45076 45072 (01)00884838088115(21)45072 45077 (01)00884838088115(21)45077 45090 (01)00884838088115(21)45090 45041 (01)00884838088115(21)45041 45091 (01)00884838088115(21)45091 45093 (01)00884838088115(21)45093 45102 (01)00884838088115(21)45102 45105 (01)00884838088115(21)45105 45120 (01)00884838088115(21)45120 45064 (01)00884838088115(21)45064 45084 (01)00884838088115(21)45084 45170 (01)00884838088115(21)45170 45118 (01)00884838088115(21)45118 45163 (01)00884838088115(21)45163 45116 (01)00884838088115(21)45116 45149 (01)00884838088115(21)45149 45141 (01)00884838088115(21)45141 45162 (01)00884838088115(21)45162 45185 (01)00884838088115(21)45185 45115 (01)00884838088115(21)45115 45186 (01)00884838088115(21)45186 45189 (01)00884838088115(21)45189 45211 (01)00884838088115(21)45211 45250 (01)00884838088115(21)45250 45224 (01)00884838088115(21)45224 45272 (01)00884838088115(21)45272 45281 (01)00884838088115(21)45281 45212 (01)00884838088115(21)45212 45231 (01)00884838088115(21)45231 45290 (01)00884838088115(21)45290 45314 (01)00884838088115(21)45314 45323 (01)00884838088115(21)45323 45268 (01)00884838088115(21)45268 45123 (01)00884838088115(21)45123 45122 (01)00884838088115(21)45122 45169 N/A 45168 (01)00884838088115(21)45168 45191 (01)00884838088115(21)45191 45220 (01)00884838088115(21)45220 45204 (01)00884838088115(21)45204 45192 N/A 45229 (01)00884838088115(21)45229 45203 (01)00884838088115(21)45203 45222 (01)00884838088115(21)45222 45228 (01)00884838088115(21)45228 45207 (01)00884838088115(21)45207 45249 (01)00884838088115(21)45249 45279 (01)00884838088115(21)45279 45278 (01)00884838088115(21)45278 45320 (01)00884838088115(21)45320 45156 (01)00884838088115(21)45156 45157 (01)00884838088115(21)45157 45085 (01)00884838088115(21)45085 45303 (01)00884838088115(21)45303 45304 (01)00884838088115(21)45304 45307 (01)00884838088115(21)45307 45305 (01)00884838088115(21)45305 45306 (01)00884838088115(21)45306 45308 (01)00884838088115(21)45308 45309 (01)00884838088115(21)45309 45311 (01)00884838088115(21)45311 45310 (01)00884838088115(21)45310 45312 (01)00884838088115(21)45312 45267 (01)00884838088115(21)45267 45001 (01)00884838088115 45008 (01)00884838088115(21)45008 45009 N/A 45036 (01)00884838088115(21)45036 45181 (01)00884838088115(21)45181 45184 (01)00884838088115(21)45184 45227 (01)00884838088115(21)45227 45217 (01)00884838088115(21)45217 45187 N/A 45292 (01)00884838088115(21)45292 45219 (01)00884838088115(21)45219 45180 (01)00884838088115(21)45180 45067 (01)00884838088115(21)45067 45094 (01)00884838088115(21)45094 45183 (01)00884838088115(21)45183 45081 (01)00884838088115(21)45081 45095 (01)00884838088115(21)45095 45028 (01)00884838088115(21)45028 45029 N/A 45030 (01)00884838088115(21)45030 45165 (01)00884838088115(21)45165 45158 (01)00884838088115(21)45158 45177 (01)00884838088115(21)45177 45174 (01)00884838088115(21)45174 45002 (01)00884838088115 45010 (01)00884838088115(21)45010 45011 (01)00884838088115(21)45011 45026 (01)00884838088115(21)45026 45027 (01)00884838088115(21)45027 45024 (01)00884838088115(21)45024 45035 (01)00884838088115(21)45035 45032 (01)00884838088115(21)45032 45051 (01)00884838088115(21)45051 45054 (01)00884838088115(21)45054 45053 (01)00884838088115(21)45053 45078 (01)00884838088115(21)45078 45068 (01)00884838088115(21)45068 45089 (01)00884838088115(21)45089 45082 (01)00884838088115(21)45082 45055 (01)00884838088115(21)45055 45086 (01)00884838088115(21)45086 45060 (01)00884838088115(21)45060 45100 (01)00884838088115(21)45100 45112 (01)00884838088115(21)45112 45099 (01)00884838088115(21)45099 45075 (01)00884838088115(21)45075 45087 (01)00884838088115(21)45087 45108 (01)00884838088115(21)45108 45113 (01)00884838088115(21)45113 45146 (01)00884838088115(21)45146 45124 (01)00884838088115(21)45124 45147 (01)00884838088115(21)45147 45164 (01)00884838088115(21)45164 45150 (01)00884838088115(21)45150 45133 (01)00884838088115(21)45133 45152 (01)00884838088115(21)45152 45161 (01)00884838088115(21)45161 45178 (01)00884838088115(21)45178 45132 (01)00884838088115(21)45132 45179 (01)00884838088115(21)45179 45194 (01)00884838088115(21)45194 45237 (01)00884838088115(21)45237 45236 (01)00884838088115(21)45236 45238 (01)00884838088115(21)45238 45243 (01)00884838088115(21)45243 45252 (01)00884838088115(21)45252 45245 (01)00884838088115(21)45245 45263 (01)00884838088115(21)45263 45261 (01)00884838088115(21)45261 45269 (01)00884838088115(21)45269 45264 (01)00884838088115(21)45264 45247 (01)00884838088115(21)45247 45296 (01)00884838088115(21)45296 45321 (01)00884838088115(21)45321 45092 (01)00884838088115(21)45092 45155 (01)00884838088115(21)45155 45058 N/A
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2419-2021
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